Vaccine Therapy in Treating Patients With Metastatic Melanoma
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||April 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003792 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Vaccine Therapy in Treating Patients With Metastatic Melanoma|
|Official Title ICMJE||Dendritic Cell Immunotherapy of Metastatic Melanoma - A Phase I Trial|
RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
OBJECTIVES: I. Determine the safety and tolerability of antigen pulsed dendritic cell therapy in patients with metastatic melanoma. II. Perform serial analysis of T cell and B cell function in these patients after this treatment. III. Determine objective response and response duration in these patients after this treatment.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SQ) on days 1-6, then undergo leukapheresis for 2-3 days, beginning on day 6. Mononuclear cells are selected for CD34+ cells in the laboratory, made into dendritic cells, and then pulsed with MART-1, gp100, tyrosinase, MAGE-3 peptides and flu matrix. These antigen pulsed dendritic cells (ApDCs) are used for vaccinations. Prior to vaccination, ApDCs are mixed with MART-1, gp100, tyrosinase, MAGE-3, and flu matrix. Patients receive this dendritic cell vaccine mixture SQ every 2 weeks for 4 priming doses. Patients receive 4 boost vaccinations SQ at 2 months, 5 months, 9 months, and 15 months following the last priming vaccination. Patients are followed monthly for 2 years.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Melanoma (Skin)|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically proven metastatic melanoma Measurable disease HLA-A2 01 phenotype No active CNS or hepatic metastases
PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Normal CD4 and CD8 T cell numbers by flow cytometry Lactic dehydrogenase less than 2 times normal Hepatic: No viral hepatitis Renal: Not specified Cardiovascular: No prior venous thrombosis, angina pectoris, or congestive heart failure Pulmonary: No prior asthma Immunologic: Positive intradermal skin test for mumps, histoplasmosis, or streptokinase antigen Immunoglobulin levels normal No prior autoimmune disease (lupus erythematosus, rheumatoid arthritis, or thyroiditis) No allergy to tetanus toxoid or influenza vaccine No sensitivity to E. coli drug preparations Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No active infection
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon At least 8 weeks since prior interleukin-2 Chemotherapy: No more than 3 prior courses of cytotoxic chemotherapy At least 8 weeks since prior chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent immunosuppressive agents
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00003792|
|Other Study ID Numbers ICMJE||CDR0000066935, BAYUMC-098004, NCI-T98-0054|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Baylor University|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||October 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP